Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039

Kourentas, Alexandros; Gajewska, M; Lin, Wen Hsing; Dhareshwar, S. S.; Steib-Lauer, Caroline; Kulkarni, Swarupa G.; Hirsch, Stefan; Heimbach, Tycho; Mueller-Zsigmondy, Martin

doi:10.1208/s12248-023-00787-5

Cited by 6 publications

(3 citation statements)

References 20 publications

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“…An industry case study presented by Tycho Heimbach, for fevipiprant, a low molecular weight, BCS class IV drug substance, has been tested in Phase 3 trials. PBBM was used to aid in setting dissolution specifications . The model included clinical pharmacokinetic data for two doses with bioequivalence (BE) and clinically observed non-BE data.…”

Section: Day Summariesmentioning

confidence: 99%

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Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report

Mackie,

Arora,

Seo

et al. 2024

Mol. Pharmaceutics

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Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM. To address this gap, industry submitted confidential PBBM case studies to be reviewed by the regulatory agencies; software companies committed to training. PBBM cases were independently and collaboratively discussed by regulators, and academic colleagues participated in some of the discussions. Successful bioequivalence "safe space" industry case examples are also presented. Overall, six regulatory agencies were involved in the case study exercises, including ANVISA, FDA, Health Canada, MHRA, PMDA, and EMA (experts from Belgium, Germany, Norway, Portugal, Spain, and Sweden), and we believe this is the first time such a collaboration has taken place. The outcomes were presented at this workshop, together with a participant survey on the utility and experience with PBBM submissions, to discuss the best scientific practices for developing, validating, and applying PBBMs. The PBBM case studies enabled industry to receive constructive feedback from global regulators and highlighted clear direction for future PBBM submissions for regulatory consideration.

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Section: Day Summariesmentioning

confidence: 99%

“…PBBM was used to aid in setting dissolution specifications. 15 The model included clinical pharmacokinetic data for two doses with bioequivalence (BE) and clinically observed non-BE data. IV microdosing data were used to describe disposition parameters.…”

Section: Day Summariesmentioning

confidence: 99%

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report

Mackie,

Arora,

Seo

et al. 2024

Mol. Pharmaceutics

Self Cite

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“…Ebola, noroviruses, hantaviruses, arenaviruses, and flaviviruses are among the RNA viruses that it may impede the replication of. [15][16][17][18]…”

Section: Therapeutic Validation Targetmentioning

confidence: 99%

Review on Favipiravir Application Uses and Adverse Effect During Covid-19

Sejal Kalra,

V. A.,

A. K.

2023

ijnrph

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The global outbreak of the COVID-19 pandemic, caused by the SARS-CoV-2 virus, has spurred an urgent search for effective antiviral medications. Favipiravir (FVP), an antiviral medicine, has emerged as a promising solution to halt the replication and spread of the virus within the human body. In this comprehensive review, we delve into the molecular mechanisms of FVP, exploring its ability to combat the coronavirus family, with SARS-CoV-2 as the primary focus. The coronavirus family, notorious for causing respiratory illnesses ranging from the common cold to severe acute respiratory syndrome (SARS), poses a significant threat to global public health. FVP, known for its anti-viral properties, has garnered attention for its potential to address the COVID-19 crisis. This review meticulously examines the harmful effects associated with FVP, shedding light on its safety margins and the evolving understanding of its deteriorating state. Despite its popularity as a go-to anti-COVID-19 drug, it is crucial to understand the nuances surrounding FVP to optimize its usage and mitigate potential risks. As the world grapples with the ongoing pandemic, understanding the intricacies of FVP's efficacy and safety profile becomes paramount. This review aims to contribute to the growing body of knowledge surrounding FVP, providing insights that are vital for healthcare professionals, researchers, and policymakers in their collective efforts to combat the global health crisis.

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Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space

Santos¹,

Ferraz²,

Issa³

et al. 2023

Journal of Pharmaceutical Sciences

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Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039

Cited by 6 publications

References 20 publications

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report

Review on Favipiravir Application Uses and Adverse Effect During Covid-19

Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space

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